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IRCT20190927044902N1 IRCT 2020-01-05 Mashhad University of Medical Sciences Effect of topical silver sulfadiazine-cerium nitrate in treatment of moderate to severe burn Comparison of the efficacy of topical silver sulfadiazine-cerium nitrate with silver sulfadiazine cream in in treatment of moderate and severe burns 2019-10-22 anticipated 112 Complete https://irct.ir/trial/42773 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization with randomization list prepared from site randomization.com, Blinding description: The patient, the treating physician and the evaluator are due to the different appearance of the formulation on the wound aware of the type of formulation (cerium nitrate will have a yellow-green appearance that produces a relatively dry scar while Silver sulfadiazine produces a damp matrix scar). They cannot be blind to the type of treatment. But the data analyzer will remain unaware of the grouping of patients until the end of the analysis. 3 Burns and corrosions. Intervention 1: control group: daily application of topical formulation of silver sulfadiazine, and closed dressing. Intervention 2: Intervention group: daily application of topical treatment with silver sulfadiazine formulation with cerium nitrate and closed dressing. Yes - There is a plan to make this available What will be shared: The mentioned data will be published in an article after the completion of the study. When: The information will be available in article for ever. To whom: any one who want Conditions: Unpublished data will be accessible after agreement of all contributors and also research deputy of Mashhad University of Medical Sciences. Where to obtain: Mail to the corresponding author How to obtain: The request should be discussed with all contributors of the study and research deputy of Mashhad University of Medical Sciences. Comments:
public Emad Molaei
School of Pharmacy, Ferdosi University Campus, Vakilabad Blvd., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 Molaeie942@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh ٍElyasi
مشهد، بولوار وکیل آباد، دانشگاه فردوسی، دانشکده داروسازی
مشهد Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Second and third degree burns according to Laund & Browder criteria Minimum burn rate of patients is 10% and maximum of 50% Patients are being hospitalized in the first 24 hours of a hospital bed. informed consent to enter the study . 18 years 70 years Both Inhalation burn Electrical and chemical burns Burns on face and hands and perineum A history of known allergies to sulfonamides History of Methemoglobinemia Pregnancy and lactation G6PD deficiency Oliguria and Anuria Functional liver disorders Lack of satisfaction with the patient to enter or continue intervention T29.0 Burn of unspecified body region, unspecified degree Treatment - Drugs Treatment - Drugs control group: daily application of topical formulation of silver sulfadiazine, and closed dressing. Intervention group: daily application of topical treatment with silver sulfadiazine formulation with cerium nitrate and closed dressing. 90% Re-epithelialization as complete restoration. Timepoint: 7, 14, 21 and 28 days after onset of treatment with formulation. Method of measurement: The Re-epithelialization rate will also be recorded as very slow (5-6 weeks), slow (about 4 weeks), moderate (2-3 weeks), or fast (about 10 days). The pain of the patient. Timepoint: once every three days. Method of measurement: The use of the visual pain criterion will be evaluated and will be graded from 0-10. Duration of hospitalization. Timepoint: Every 5 days. Method of measurement: Based on the percentage of grafts taken on day 5. Infection frequency. Timepoint: Every week. Method of measurement: Wound culture. Mashhad University of Medical Sciences Approved 2019-09-20 Ethics committee of Mashhad University of Medical Sciences Ghoreishi Building, Daneshgah Street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)